Today, June 26th, we received the following Certified Letter, accompanied by a GC/MS analysis, four more pages of lab analysis, and a photo of two of our retail bottles of Wintergreen.  It was also accompanied by three large government pamphlets. None of which specify what labeling our product should have.  Evidently "keep out of reach of children" and "for external use only" are not enough.  And a built in orifice reducer does not constitute "Childproof Packaging."

The fact that he got both my name and the business address wrong is irrelevant. Maybe that's why I got it so late.

The letter states that we have 10 days, until June 30, to respond. (Five days, since it seems to have taken 6 days to reach us.

Tel: (301) 504-7300
Fax: (301) 504-0359
Email: jboja@cpsc.gov

JUN 20, 2006.

via Certified Mail / Telecopy (615) 612-4270

Re: CPSC Sample   06-810-3842 Wintergreen Essential oil, 15 ml

Dear Ms. Clark:

The U.S. Consumer Product Safety Commission (CPSC) administers the Federal Hazardous Substances Act (FHSA) and the Poison Prevention Packaging Act (PPPA), and their accompanying regulations at 16 C.F.R. Part 1500 and 16 C.F.R. Part 1700, respectively. The FHSA requires that hazardous household substances bear cautionary labeling for their safe use and storage. The PPPA requires that certain household substances, be packaged in special (child-resistant/senior-friendly) packaging. The PPPA regulation at 16 C.F.R. § 1700.14(a)(3) requires special packaging for products containing more than 5 percent by weight of methyl salicylate. The CPSC staff examined the samples referenced above that were collected by a CPSC investigator during an inspection of your firm on May 10, 2006. The examination revealed that the products represented by the subject samples contain over 5 percent of methyl salicylate (laboratory report attached) and fail to meet the special packaging requirements of the PPPA and the labeling requirements of the FHSA. Consequently, those products sold to consumers for use and storage in and around the home are "misbranded hazardous substances" under section 2(p) of the Federal Hazardous Substances Act (FHSA) and distribution of these products is prohibited. The Commission staff requests that you immediately stop sale of these products to consumers and correct future production of this and similarly misbranded hazardous substances. Young children may be exposed to a risk of poisoning or other injury due to accidental ingestion of these products.

The product represented by CPSC sample 06-810-8342 consists of a clear liquid packaged in a cobalt blue, glass bottle with a dropper insert in the neck of the bottle, with a white, continuously-threaded closure with a tamper evident ring. The immediate container is labeled in the front "Pure Essential Oil   ... Wintergreen ... (Gaulteriafragrantissimus)... Steam

CPSC Holline: 1-800-638-CPSC(2772)    CPSC's Web Site: htlp://www.cpsc.gov  

Marjory Clark Page 2

Distilled, Wild,... (Nepal, leaves ... Hazardous!!.. Avoid prolonged use". One side panel is labeled in part, "Nature's Gift ... Aromatherapy Products ... Madison, TN". The other side panel is labeled in part "Keep out of the reach of children ... for external use only... always dilute in carrier oil for use on skin ... keep away from eyes". CPSC laboratory testing revealed that the product contains 96.24% wt/wt of methyl salicylate.

Ingestion of 7.5 ml of oil of wintergreen has been reported to be fatal in a child, however ingestion of as little as 4 ml can be fatal. The labeling on the product does not note this hazard and fails to meet the minimum labeling requirements of the FHSA. Please refer to the FHSA regulation at 16 C.F.R. § 1500.121 for recommendations.

Hazardous substances that are not labeled in compliance with the FHSA and/or that are not packaged in accordance with the PPPA are misbranded hazardous substances, 15 U.S.C. § 1261 (p). Distribution and sale of a misbranded hazardous substance is a prohibited act under section 4 of the FHSA. The enclosed Compilation of Statutes Administered by CPSC contains the FHSA, 15 United States Code (U.S.C.) § 1261 et seq. Any person who violates any of the provisions of section 4 shall be guilty of a misdemeanor and shall on conviction thereof be subject to a fine of not more than $5,000 ($10,000 for organizations) or to imprisonment for not more than ninety days, or both. For offenses committed with intent to defraud or mislead, or for second and subsequent offenses, the penalty shall be imprisonment for not more than one year, and/or fines as follows:

Organizations:

Not more than $200,000 if the offense does not result in death. Not more than $500,000 if the offense results in death.

Individuals:

Not more than $100,000 if the offense does not result in death. Not more than $250,000 if the offense results in death.

You could also be subject to civil penalties under the FHSA for knowingly violating section 4 of the FHSA, a maximum of $8,000 per violative product up to a maximum of $1,825 million for any related series of violations, 15 U.S.C. § 1264(c). Knowingly means having actual knowledge or the presumed having of knowledge deemed to be possessed by a reasonable person who acts in the circumstances, including knowledge obtainable upon the exercise of due care to ascertain the truth of representations.

If you disagree with the Commission staffs finding that the labeling of the subject products does not meet the minimum labeling requirements of the FHSA, Chapter 2 of the Handbook describes the procedures for presenting your views and any supporting evidence to the staff. Copies of the Compilations of Statutes Administered by the CPSC, which contain the PPPA and the PPPA regulations are enclosed.

Marjory Clark Page 3

Please respond within ten (10) working days of the date of this letter outlining the corrective actions your firm will take with respect to this and similarly misbranded products. Chapter 7 of the Handbook includes information regarding the confidential treatment of information you submit in response to this letter. Your cooperation in this matter is appreciated.

Sincerely,

John Bpja Compliance Officer

Enclosures:     Compilation of Statutes PPPA Regulations Regulated Products Handbook Laboratory reports for CPSC sample 06-810-3842

Since I don't offer drain cleaner, and the cautions don't seem to apply, I am not certain how they think I should label a product that I already give extensive warnings, both on the label and on our website.

Beware if you sell essential oils.  You may be next.